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NCT Number: NCT03184038

Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery

This phase II trial studies the neurological function in patients with multiple brain metastases undergoing stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Assessment of neurocognitive function may help show that SRS preserves neurological function in patients with multiple brain metastases better than SBRT.

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Key information

Conditions

Metastatic Malignant Neoplasm in the Brain Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Metastatic Malignant Solid Neoplasm Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jefferson Health New Jersey, Sewell, New Jersey, United States

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About this study

PRIMARY OBJECTIVES:

I. Assessment of neurocognitive function at months 4.

SECONDARY OBJECTIVES:

I. Assessment of neurocognitive function at months 4 and 12 as measured by neurocognitive decline on a battery of tests.

II. Assessment of symptom burden, as measured by the M.D. Anderson Symptom Inventory- Brain Tumor Module (MDASI-BT).

III. Assessment of quality adjusted survival and health outcomes using the European Quality of Life Five Dimension Five Level scale questionnaire (EQ-5D-5L).

IV. Assessment of local control, in brain control. V. Assessment of progression free survival (PFS), and overall survival (OS). VI. Assessment of side effects and toxicities.

OUTLINE:

Patients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline, 4, and 12 months after undergoing SRS or SBRT.

After completion of study, patients are followed up at 2, 4, 6, 8, 10, and 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathologically proven solid tumor malignancy (except for small cell lung cancer [SCLC], germ cell tumor)
  • Karnofsky performance status >= 60
  • 1 to 10 brain metastases (mets) (no more than two lesions and/or cavities >= 3 cm in maximum diameter)
  • Maximum diameter of brain metastasis or resection cavity is 6 cm
  • Serum creatinine =< 3 mg/dL and creatinine clearance >= 30 ml/min
  • Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up; patients must be willing to complete neurocognitive assessments at pre-specified time points outlined in the protocol
  • Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 21 days prior to registration
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose
  • Patient able to provide his/her own written informed consent and speak English

Exclusion criteria

  • Patient with diagnosis of glioma, or other World Health Organization (WHO) grade II - IV primary brain tumor
  • Prior brain surgery =< 14 days prior to enrollment
  • Planned chemotherapy during radiosurgery
  • Leptomeningeal metastases
  • Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per week for the past 2 months
  • Pregnant women

Treatment and study plan

cognitive assessment

Procedure

Undergo assessment of neurocognitive function

Stereotactic Radiosurgery

Radiation

Undergo SRS

Other names: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery

Stereotactic Body Radiation Therapy

Radiation

Undergo SBRT

Other names: SBRT, SABR, Stereotactic Ablative Body Radiation Therapy

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Primary outcomes

  1. Neurocognitive function as measured by neurocognitive decline on a battery of tests

    Time frame: At 4 months

    The proportion of patients with neurocognitive decline at 4 months post stereotactic radiosurgery (SRS) treatment in each group will be estimated using the sample proportion with the corresponding two-sided 95% confidence interval. The determination of neurocognitive decline will be based on a battery of tests: Hopkins Verbal Learning Test-Revised (HVLT-R) for Total Recall, Delayed Recall, and Delayed Recognition, Controlled Oral Word Association (COWA), and the Trail Making Test (TMT) Parts A and B. The operative definition for neurocognitive decline in this study will be decline on at least one of these measures.

Secondary outcomes

  1. Change in neurocognitive function as measured by neurocognitive decline on a battery of tests conducted by the primary investigator or a trained member of the clinical team

    Time frame: Baseline to up to 12 months

    Each patient will serve as his or her own control, and the relative decline in HVLT-R scores from baseline to pre-specified post-treatment internals will be defined as follows: ΔHVLTi = (HVLTB - HVLTF) ÷ HVLTB, where B = baseline and F = follow-up. A positive change indicates a decline in function. Comparison of HVLT-R DR results between control and different time points will be tested using the one-side Wilcoxon signed rank test with significance level of .05. The repeated measures of each neurocognitive test (HVLT-R, COWA, and TMT) and the health-related quality of life (HR-QOL) scale at 2, 4, 6, and 12 months will be analyzed using a linear mixed effects model. The dichotomous indicator of neurocognitive decline based on this battery of tests at 2, 4, 6, and 12 months will be analyzed using a repeated measures logistic regression model.

  2. Change in symptom burden as measured by the MD Anderson Symptom Inventory- Brain Tumor Module (MDASI-BT)

    Time frame: Baseline to up to 12 months

    Four subscales (symptom severity, symptom interference, neurologic factor, and cognitive factor score) as well as certain individual items (fatigue, neurologic factor items, and cognitive factor items) of the MDASI-BT will be analyzed. For discrete time point analyses, the change from baseline to each follow-up time point (2, 4, 6, and 12 months from the start of treatment) will be calculated and compared between treatment arms using a t-test or Wilcoxon-Mann-Whitney test, depending on the normality of the data.

  3. Quality adjusted survival and health outcomes as measured by the European Quality of Life Five Dimension Five Level scale questionnaire (EQ-5D-5L)

    Time frame: Up to 12 months

    The Z-test will be used to test the hypothesis that the health outcomes in the 2 treatment groups is the same at different time points after initiation of treatment with a significance level of 0.05 and a 2-sided test.

  4. Local control as measured by magnetic resonance imaging

    Time frame: Up to 12 months

    Will be measured by magnetic resonance imaging.

  5. Progression free survival (PFS)

    Time frame: Up to 12 months

    Each group will be evaluated using the Kaplan-Meier method.

  6. Overall survival (OS)

    Time frame: Up to 12 months

    Each group will be evaluated using the Kaplan-Meier method.

  7. Incidence of adverse events graded according to the Common Terminology Criteria for Adverse Events version 5.0

    Time frame: Up to 30 days after SRS

    Descriptive analysis will be performed on the acute toxicity data. All estimates of rates (e.g., discontinuation rate and rates of other toxicities) will be presented with corresponding confidence intervals.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenyin Shi, MD

CONTACT

[email protected]

(215) 955-6702

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Registry information

Official study title

Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2017
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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